Bismuth IIIb or IV perihilar cholangiocarcinoma
Conditions
Interventions
Experimental:Preoperative embolization of the affected right hepatic artery followed by resection without reconstruction
Sponsors
SUN YAT-SEN MEMORIAL HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily join this study and sign the informed consent form; 2. Age 18-80 years (inclusive), no gender restriction; 3. Disease diagnosis: (1) Based on clinical manifestations, tumor markers, and imaging features (CT/MRI/MRCP showing hilar bile duct stricture, thickened duct wall or mass, and intrahepatic bile duct dilation), the clinical diagnosis of perihilar cholangiocarcinoma is determined through multidisciplinary team discussion. (2) The type meets Bismuth-Corlette type IIIb or IV, and a curative outcome can be achieved through left liver or left trisectionectomy. 4. Vascular invasion characteristics (core criteria): (1) Preoperative imaging (CTA/MRA) suggests tumor invasion of the right hepatic artery (RHA), evaluated as "difficult to safely reconstruct after resection." Meeting any one of the following conditions is considered that the right hepatic artery cannot be safely reconstructed after resection: Tumor invasion involves the right hepatic artery and its branches (anterior/posterior branches); the length of the invaded right hepatic artery is too long, making tension-free end-to-end anastomosis impossible after resection, requiring vascular grafting to complete reconstruction. (2) The portal vein of the preserved right side of the liver (main trunk/right portal vein) is not invaded, or the invaded area is limited and can be safely resected and reconstructed. 5. Physical condition and survival expectation: ECOG performance status score 0-1. KPS quality of life score >= 60. Expected survival time >= 12 weeks. 6. No severe cardiac diseases, cerebrovascular diseases, or pulmonary diseases; 7. No history of malignant tumors in tissues or organs outside the liver; 8. Organ function reserve: The patient must have sufficient organ function to tolerate major surgery and interventional embolization, with laboratory test indicators meeting the following (within 7 days of screening): (1) Hematology: absolute neutrophil count (ANC) >= 1.5 × 10^9/L. Platelet count (PLT) >= 80 × 10^9/L. Hemoglobin (HGB) >= 90 g/L. (2) Liver function: total bilirubin (TBIL) = 30 g/L. Child-Pugh classification grade A or B (<= 7 points). Indocyanine green 15-minute retention rate (ICG-R15) < 10%. Coagulation function: international normalized ratio (INR) <= 1.5.
Exclusion criteria
Exclusion criteria: 1. Distant metastasis: Preoperative imaging (such as PET-CT, thoracoabdominal-pelvic CT) suggests the presence of distant metastasis (M1), including peritoneal implantation, unresectable intrahepatic lobe metastasis, extraregional lymph node metastasis (such as para-aortic or retro-pancreatic lymph nodes), bone, lung, and other distant organs. 2. History of other malignancies within the past 5 years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). 3. Severe comorbidities: Severe cardiovascular and cerebrovascular diseases (such as myocardial infarction within the past 6 months, unstable angina within the past 1 month, NYHA class III-IV heart failure, uncontrolled arrhythmia, occurrence or worsening of congestive heart failure within the past 30 days). Severe respiratory diseases (such as FEV1 1.8 mg/dL (or > 160 µmol/L). Uncontrolled active infections (such as severe suppurative cholangitis, septicemia) that require intravenous antibiotics and cause hemodynamic instability. ASA score > 3; BMI >= 35. 4. Allergies and contraindications: severe allergy to iodinated contrast agents that cannot be alleviated by pretreatment, or the presence of contraindications to angiography. 5. Pregnant or breastfeeding women. 6. Postoperative pathology confirming non-cholangiocarcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-Year Overall Survival Rate; | — |
Countries
China
Contacts
Public ContactChao Liu
SUN YAT-SEN MEMORIAL HOSPITAL
Outcome results
None listed